BEUDAMED
    FDA Enforcement Class II Terminated

    syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.

    Recall: Z-1944-2014 · Reported July 9, 2014

    Enforcement

    Recall Number
    Z-1944-2014
    Event ID
    68394
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Healthcare Diagnostics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 9, 2014
    Initiation Date
    May 20, 2014
    Classification Date
    June 30, 2014
    Termination Date
    August 10, 2015
    Address
    500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, 19702-2466, United States

    Description

    syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.

    Reason

    Certain configuration parameters may cause the reference ranges to not hold results as expected and release them to the Laboratory Information System (LIS) that should have been held for manual review.

    Code Info

    syngo Lab Data Manager Application Software versions VA11B, VA12A, and VA12B

    Distribution

    Worldwide Distribution. US Nationwide, Canada, Australia, Belgium, Czech Republic, Germany, Denmark, Finland, France, United Kingdom, Italy, Netherlands, Portugal, Slovakia, Singapore, Japan, and Spain.

    Quantity

    336